"Innovent Biologics has received approval from China’s National Medical Products Administration (NMPA) for SYCUME® (teprotumumab N01).
TED is a condition that affects around 25% to 50% of individuals with Graves’ disease and can also occur in those with other thyroid disorders or normal thyroid function. The disease progression includes active and inactive phases, with symptoms such as dry eye, photophobia, diplopia, and periorbital oedema.
SYCUME® (teprotumumab N01) is a recombinant anti-IGF-1R antibody developed for TED treatment. IGF-1R, a transmembrane tyrosine kinase receptor, plays a role in development, metabolism, and immune regulation and is overexpressed in orbital fibroblasts, B cells, and T cells of TED patients.
This recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody is the first of its kind in China and the second globally to gain regulatory approval.
It marks a significant advancement in the treatment of thyroid eye disease (TED), providing a new therapeutic option after decades without innovation in this area.
The approval of SYCUME® is based on findings from the Phase 3 RESTORE-1 trial, which met its primary endpoint in 2024.
The study demonstrated that 85.8% of patients experienced a reduction of at least 2 mm in proptosis by Week 24, with significant improvements in inflammation and quality of life.
The RESTORE-1 results have been presented at major conferences, including the World Ophthalmology Congress, the Annual Meeting of the Chinese Society of Endocrinology, and the Congress of the Chinese Ophthalmological Society, gaining recognition from experts in the field.
Innovent Biologics continues to advance therapeutic innovations aimed at improving patient outcomes in ophthalmology and endocrinology.